Icecure Medical Ltd recalls IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the ap…

Recall date

September 16, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2650-2023

FDA classification

Class II

Brand / firm

Icecure Medical Ltd

Sold / distributed

US Nationwide distribution.

Why it was recalled

Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)